FDA Approves Zometa for Cancer-Related Bone Complications

FDA Approves Zometa for Cancer-Related Bone Complications

EAST HANOVER, New JerseyThe US Food and Drug Administration has
approved the Novartis drug Zometa (zoledronic acid for injection) for the
treatment of patients with multiple myeloma and patients with documented
bone metastases from solid tumors, in conjunction with standard
antineoplastic therapy.

These solid tumors include prostate cancer, lung cancer, breast cancer,
and other solid tumor types. In prostate cancer, patients should have
progressed after treatment with at least one hormonal therapy.

The trials that led to the approval mark the first time any
bisphosphonate has shown efficacy in treating bone complications in patients
with prostate cancer, lung cancer, and other solid tumors, Novartis said in
a news release. Further, Zometa offers patients, nurses, and clinicians a
convenient 4 mg, 15-minute infusion time.

Novartis submitted the new drug application (NDA) for the bone metastases
indication to the FDA in August 2001, and in October 2001, the NDA received
a priority review designation. Zometa was previously approved for the
treatment of hypercalemia of malignancy.

The approval is based on data from three large international clinical
trials evaluating more than 3,000 patients with prostate, lung, and breast
cancer, and other solid tumors, and multiple myeloma. In two
placebo-controlled studies in patients with bone metastases from prostate
cancer or other solid tumors, both the number of patients with skeletal
events and the time to first skeletal-related event were decreased, compared
with placebo.

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